Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions

NCT01698190 | Unknown

• 1 other identifier: SBUGI-2012
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.

Conditions

Pancreatic Tumor; Gastric Tumor; Esophageal Tumor; Lymphadenopathy; Duodenal Tumor

Outcome Measures

Primary Outcomes (1)

• Number of needle passes needed to obtain a pathologic diagnosis.

  Within 1 week of study enrollment

Secondary Outcomes (3)

• Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB.

  By three months post-op in the pathology report

• Visible core specimens obtained and its correlation to obtaining a diagnostic sample.

  During the intervention itself

• Frequency of adverse side effects.

  Three months post-op

Study Arms (2)

Fine needle aspiration (FNA)

ACTIVE COMPARATOR

Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle

Procedure: Endoscopic ultrasound guided needle tissue acquisition.

Fine needle biopsy (FNB)

ACTIVE COMPARATOR

Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy).

Procedure: Endoscopic ultrasound guided needle tissue acquisition.

Interventions

Endoscopic ultrasound guided needle tissue acquisition. PROCEDURE

Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.

Also known as: Echotip ProCore

Fine needle aspiration (FNA); Fine needle biopsy (FNB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive adult patients who require endoscopic ultrasound and tissue sampling of either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus, stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located adjacent to the esophagus, stomach, duodenum or rectum
• Ability to give consent

You may not qualify if:

• Inability to obtain informed consent
• Pregnant patients
• Patients under the age of 18
• Severe cardiopulmonary disease preventing a safe EUS procedure
• Patients unable to safely stop anti-coagulation therapy prior to EUS procedure

Sponsors & Collaborators

• Stony Brook University: lead
• New York Medical College: collaborator
• Yale University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Columbia University: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (8)

• ASGE Standards of Practice Committee; Gan SI, Rajan E, Adler DG, Baron TH, Anderson MA, Cash BD, Davila RE, Dominitz JA, Harrison ME 3rd, Ikenberry SO, Lichtenstein D, Qureshi W, Shen B, Zuckerman M, Fanelli RD, Lee KK, Van Guilder T. Role of EUS. Gastrointest Endosc. 2007 Sep;66(3):425-34. doi: 10.1016/j.gie.2007.05.026. Epub 2007 Jul 23. No abstract available.

  PMID: 17643438 BACKGROUND

• Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.

  PMID: 9087830 BACKGROUND

• Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.

  PMID: 9097990 BACKGROUND

• Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12.

  PMID: 21483464 BACKGROUND

• Schwartz DA, Unni KK, Levy MJ, Clain JE, Wiersema MJ. The rate of false-positive results with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2002 Dec;56(6):868-72. doi: 10.1067/mge.2002.129610.

  PMID: 12447300 BACKGROUND

• Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.

  PMID: 21420083 BACKGROUND

• Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.

  PMID: 21611946 BACKGROUND

• Nagula S, Pourmand K, Aslanian H, Bucobo JC, Gonda TA, Gonzalez S, Goodman A, Gross SA, Ho S, DiMaio CJ, Kim MK, Pais S, Poneros JM, Robbins DH, Schnoll-Sussman F, Sethi A, Buscaglia JM; New York Endoscopic Research Outcomes Group (NYERO). Comparison of Endoscopic Ultrasound-Fine-Needle Aspiration and Endoscopic Ultrasound-Fine-Needle Biopsy for Solid Lesions in a Multicenter, Randomized Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1307-1313.e1. doi: 10.1016/j.cgh.2017.06.013. Epub 2017 Jun 15.

  PMID: 28624647 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Lymphadenopathy; Duodenal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Intestinal Neoplasms; Duodenal Diseases; Intestinal Diseases

Study Officials

• Satish Nagula, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish Nagula, M.D.

CONTACT

631-444-2119; satish.nagula@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: October 2, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

US (1)